Compressive Device for Percutaneous Treatment of Obesity

ABSTRACT

An apparatus and method for treating morbid obesity in mammals using a gastric reduction assembly that reduces the gastric volume of a stomach and induces early satiety. The gastric reduction assembly comprises at least two or more expandable devices, each able to be adjustably inflated with a fluid (e.g., a liquid or a gas) using a filling tube. In a preferred embodiment, the gastric reduction assembly is inserted through the abdominal wall and placed at a location exterior to the stomach body, avoiding an abdominal incision. Once positioned near the stomach body, the gastric reduction assembly allows for the external compression of the stomach body to limit food intake. The gastric reduction assembly also minimizes the potential for shifting of the expandable devices after insertion to the stomach body to revert to its pre-compressed state.

The benefit of the filing date of provisional application Ser. No.60/494,698, filed 13 Aug. 2003 is claimed under 35 U.S.C. §119(e).

TECHNICAL FIELD

This invention pertains to multiple expandable devices that can beimplanted to treat obesity in mammals by reducing the volume of thestomach.

BACKGROUND ART

Obesity is a complex, medical disease affecting more than 30% of thepopulation in the United States. Obesity affects an individual'spersonal quality of life and contributes significantly to morbidity andmortality. Obese patients, i.e. individuals having a body mass index(“BMI”) greater than 30, often have a high risk of associated healthproblems (e.g., diabetes, hypertension, and respiratory insufficiency),including early death. In the United States, approximately 280,000deaths annually are attributed to obesity and obesity-related diseases.In the case of morbid obesity, studies have shown that conservativetreatment with diet and exercise may be ineffective for reducing excessbody weight. In addition, specific diets, medications, behavioralmodifications, and exercise programs have over a 95% failure rate inmorbidly obese individuals. Consequently, surgery is often the mosteffective means of treatment. “Bariatric surgery” is the field ofsurgery that treats people who are so overweight that they are sufferinghealth consequences due to the excess weight. The surgery usuallyinvolves operations on the stomach to restrict one's ability to eat, oron the small intestine to restrict the absorption of ingested food. SeeM. Deitel, “Overview of Obesity Surgery,” World J. Surg., vol. 22, pp.913-918 (1998).

A successful bariatric surgery results in a maintained weight loss ofgreater than 50% of excess body weight and in an increase in patientwellness. An important factor for success is a long-term relationshipbetween the patient and a medical team, which includes the doctorperforming the procedure, a dietitian, a psychologist, and a physicaltherapist. While current bariatric surgery may assist patients inreducing food intake, it may also increase medical risks due tocomplications inherently associated with surgery, includingcomplications of anesthesia, surgical procedure, wound infections,dehiscence, stomal stenosis, marginal ulcers, thrombophlebitis, andpulmonary problems.

There are several bariatric surgical procedures for treating morbidobesity. One procedure for treating morbid obesity is referred to as a“biliopancreatic diversion.” Biliopancreatic diversion surgery is areduction of the stomach volume and a diversion of food from the stomachto the final segment of the small intestine, bypassing the beginning andmiddle portions of the small intestine to limit the amount of nutrientsand calories absorbed by the body. This procedure removes about one halfof the stomach, and then connects the stomach to the last 250 cm of thesmall intestine. Disadvantages of this surgery include patientssuffering from protein malnutrition, anemia, gastric retention,diarrhea, abdominal bloating, and intestinal obstruction. See P.Marceau, et al., “Malabsorptive Obesity Surgery,” Surg. Clinics of NorthAmerica, vol. 81(5), pp. 1113-28 (2001).

Another bariatric surgery, “gastric bypass,” is a bypass connecting thelower compartment of the stomach to the initial portion of the smallintestine. This procedure limits the amount of food that can be ingestedat one sitting and reduces absorption of food across the smallintestine. In addition to surgical complications, patients may alsosuffer from acute gastric dilation, anastomotic leak, anemia, anddumping syndrome. See R. E. Brolin, “Gastric Bypass,” Surg. Clinics ofNorth America, vol. 81(5), pp. 1077-1096 (2001).

A third bariatric surgical procedure is “gastric banding,” whichconstricts the stomach to form an hourglass shape. This procedurerestricts the amount of food that passes from one section to the next,which induces a feeling of satiety. A band is placed around the stomachnear the junction of the stomach and esophagus. The small upper stomachpouch is filled quickly, and slowly empties through the narrow outlet toproduce a feeling of satiety. In addition to surgical complications,patients undergoing this procedure may also suffer from esophagealinjury, splenic injury, band slippage, staple line disruption, reservoirdeflation/leak, and persistent vomiting. See E. J. DeMaria,“Laparoscopic Adjustable Silicone Gastric Banding,” Surg. Clinics ofNorth America,” vol. 81(5), pp. 1129-44 (2001).

A fourth bariatric surgical procedure is “vertical-banded gastroplasty,”which restricts the volume of the stomach by using staples. In thisprocedure, staples are placed in the upper stomach region to create asmall pouch with a narrow outlet to the remaining portion of thestomach. A lap-band is placed around the narrow outlet to providesupport and inhibit stretching of the stomach. In addition to surgicalcomplications, patients undergoing this procedure may suffer fromvomiting, ulcers, band erosion, and leaks. See C. Doherty, “VerticalBanded Gastroplasty,” Surg. Clinics of North America, vol. 81(5), pp.1097-1112 (2001).

U.S. Pat. No. 6,102,922 describes a device and surgical method forreducing the food intake of a patient by forming a restriction in thestomach using a band. In one embodiment, the band is looped around theesophagus and a portion of the stomach is pulled up through the bandloop. This forms a small stomach pouch and a narrow outlet to theremaining portion of the stomach. This allows for a quick filling of thesmall stomach pouch, and a slow emptying of the stomach through thenarrow outlet to produce a feeling of satiety.

U.S. Pat. No. 6,475,136 describes a device for treating heartburn andreflux disease by restricting the amount of food flowing into a stomachor an esophagus, comprising a restriction device (a sphincter or a cuff)that can be adjusted. In one embodiment, the restriction device performslike an artificial sphincter that opens and closes the food passagewayin the stomach. In an alternative embodiment, the restriction devicecomprises an adjustable cuff, a clamp, or a roller to bend or rotate theesophagus or stomach to close or almost close the junction between thestomach and esophagus.

U.S. Pat. No. 4,246,893 describes a device and method for treatingobesity by compressing the stomach and reducing its capacity using asingle adjustable distensible device (e.g., a balloon) whose volume canbe adjusted from an external port.

U.S. Pat. No. 5,993,473 and WO 99/25418 describe a device and surgicalmethod for treating obesity by decreasing the volume of the stomach byusing a single expandable device placed inside the stomach cavity.

U.S. Pat. No. 4,694,827 describes a device and method for controllingobesity by deterring ingestion of food using a single balloon that isplaced inside the stomach.

U.S. Publication No. 2002/0188354 describes a device for treatingobesity by inserting an hourglass-shaped device into the junctionbetween the stomach and the small bowel, which delays gastric emptyingof food.

U.S. Pat. No. 6,511,490 describes a device for the treatment of morbidobesity by restricting food passage in the stomach by placing aninflatable band around the stomach to create a pouch with a smallopening adjacent to the esophagus. The inflatable band is secured andthen inflated until the appropriate sized opening is achieved.

DISCLOSURE OF INVENTION

We have discovered an apparatus and method for effectively treatingmorbid obesity in mammals, while minimizing the health risks associatedwith traditional surgery. The device reduces the gastric volume of thestomach and induces early satiety. The “gastric reduction assembly”comprises at least two or more expandable devices (e.g., balloons), eachable to be independently inflated and adjusted from an external port.Each expandable device can be filled with a fluid (e.g., CO2, isotonicdextrose solution, isotonic saline solution, etc.) using a filling tube(e.g., a catheter), which can be easily accessed externally. In apreferred embodiment, the gastric reduction assembly is insertedpercutaneously through the antero-lateral abdominal wall, and placed ata location exterior to the stomach body, avoiding an abdominal incision.Laparoscopic guidance, optionally, may be used to assist in placing thegastric reduction assembly near the stomach body. Once positioned nearthe stomach body, the gastric reduction assembly can be inflated tocompress the volume of the stomach and effectively limit food intake.The gastric reduction assembly, with multiple expandable devices,minimizes the potential for post-implantation movement. The expandabledevices have a size and shape to complement each other, such that theyform a barrier when inflated that minimizes post implantation movement.

To further minimize inferior migration, a subcutaneous anchor (e.g., aballoon or ring placed within the fatty layer between the skin and theabdominal wall), may be attached to the filling tubes to anchor theexpandable devices to the abdominal wall. In addition, each expandabledevice may use an intragastric anchor (e.g., a collapsible fixationdisc) to anchor the expandable device against the stomach body.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a perspective view of one embodiment of the gastricreduction assembly, implanted in the peritoneal cavity around thestomach.

FIG. 2 illustrates a front view of one embodiment of the gastricreduction assembly which has three expandable devices: twospherical-shaped and one crescent-shaped.

The invention provides a reliable, inexpensive method for treatingobesity in mammals by reducing the volume of the stomach withoutabdominal surgery, thus reducing postoperative surgical complications.The gastric reduction assembly can provide either an intraperitoneal oran extraperitoneal method to compress the stomach. The placement dependson the surgeon's preference, and the physical condition and body habitusof the patient. In the intraperitoneal cavity, expandable devices can beplaced either at a pregastric location (i.e., either anterior oranterolateral to the stomach) or a retrogastric location (i.e., eitherposterior or posterolateral to the stomach), or both. In theextraperitoneal cavity, the expandable devices can be placed in any ofthe anatomical compartments, spaces, or layers of the abdominal wall.Candidates for this minimally invasive procedure include patients with aBMI greater than 40, or patients with a BMI less than 40 and adebilitating disease related to the obesity such as diabetes,hypertension, and respiratory insufficiency.

MODES FOR CARRYING OUT THE INVENTION

The basic design comprises a gastric reduction assembly having at leasttwo or more expandable devices (e.g., balloons), each able to beadjusted and independently inflated. Each device can be inflated with afluid (e.g., CO₂, isotonic dextrose solution, isotonic saline solution,etc.) using a filling tube. The filling tube is accessed externally byway of an access device. To inflate each expandable device, the inlet ofeach filling tube is attached to a corresponding port, and fluid isinjected into the inlet via a carrier (e.g., a hypodermic syringe).Fluid flows through the filling tube into each expandable device.Alternatively, fluid can be removed by reversing the process. Thefilling tubes may be locked together inside a single catheter or otherlarge tubing such that only one tube crosses the abdominal wall to theaccess port.

In a preferred embodiment, compression of the stomach is achieved usingtwo or more spherical-shaped expandable devices to form a compressivebarrier that reduces the volume of the stomach and minimizespost-implantation movement. Optionally, at least one crescent-shapedexpandable device may be used to support the spherical-shaped expandabledevices. The shape of the barrier formed by the multiple expandabledevices may be adjusted to complement that of surrounding tissues andorgans of the patient by changing the volume of the devices.

To further minimize post-implantation movement, a subcutaneous anchormay be used to help anchor the expandable devices to the abdominal wall.In one embodiment, the subcutaneous anchor is a balloon-like deviceadapted to circumscribe the filling tubes subcutaneously or below theabdominal wall, at the muscular layer level. The volume of thesubcutaneous anchor is adjusted by adding fluid. Alternatively, a ringlock may be placed around each filling tube at the muscular layer. Inanother embodiment, the expandable devices may be anchored to thestomach using an anchor e.g., a collapsible, fixation disc placed insidethe stomach. One method of placement is to pass the intragastric anchorthrough a separate tube that crosses the expandable device and endsinside the stomach cavity. The tube can be accessed externally.

The expandable devices can be implanted by passing through the skin andacross the anterior abdominal wall via a larger tube to a predeterminedimplantation site. The expandable devices remain at the site, attachedto filling tubes that can be accessed externally through a small singleaccess port.

The gastric reduction assembly has several advantages. First, thepotential for incisional hernia and wound infections is substantiallyreduced, since no surgical incision of the abdominal wall is needed. Theexpandable devices are inserted through the skin and across the anteriorabdominal wall via a small puncture. The access device for refilling ordeflating the expandable devices is placed in the fatty layers of theabdomen, between the skin and the anterior abdominal muscles. Second,post-implantation movement is substantially reduced, almost eliminatinga need to re-orient the expandable devices following implantation.Third, modifications (e.g., inflation, deflation, reorientation, orremoval) may easily be done without surgery.

FIG. 1 illustrates a perspective view of one embodiment of the gastricreduction assembly 2, in accordance with the present invention. In thisembodiment, the device comprises an access device 6, a subcutaneousanchor 8, and at least two or more expandable devices 4, each having anintragastric anchor 10 and a filling tube 12. Multiple expandabledevices 4 are sized and shaped to complement each other such that wheninflated, they cluster to form a compressive barrier capable of reducingthe stomach volume and minimizing post-implantation movement. Toadjustably inflate the expandable devices 4 in the peritoneal cavity,fluid is injected into each filling tube 12 of each expandable device 4via the access device 6.

As shown in FIG. 1, gastric reduction assembly 2 comprises threespherical-shaped expandable devices 4 (e.g., balloons) placed at apregastric location. Alternatively, gastric reduction assembly 2 maycomprise another number of expandable devices 4 (e.g., two, four, five,six, etc.). Optionally, at least one crescent-shaped expandable device13 may be used, as shown in FIG. 2. This enhances the compressivebarrier by forming a carrier ridge to support spherical-shapedexpandable devices 4. Expandable devices 4 can be made of any durable,distensible biocompatible material, such as rubber, latex, orpolyurethane elastomer.

As shown in FIG. 1, each filling tube 12 has an inlet at the accessdevice 6 and an outlet to the interior of each expandable device 4 toallow for inflation with fluid. In an alternative embodiment, a singlefilling tube 12 that has an inlet and outlet (not shown) for eachexpandable device 4 may be used. Filling tubes 12 should be made of adurable, flexible, biocompatible material, such as TYGON® tubing,polyurethane, or other plastics.

As shown in FIG. 1, subcutaneous anchor 8 is a distensible balloon-likedevice that circumscribes filling tubes 12 within the fatty layerbetween the skin and abdominal wall or at a subperitoneal (i.e., belowthe abdominal wall) region to anchor the expandable devices 4 to theabdominal wall. The balloon-like device is inflated via its own fillingtube 14. Alternatively, subcutaneous anchor 8 can be a ring lock (notshown) that joins all filling tubes 12. When the ring lock is placedaround filling tubes 12 and advanced towards the abdominal wall, itforms an anchor against the muscular layer of the abdominal wall.Subcutaneous anchor 8 should be made of a durable, distensiblebiocompatible material, such as rubber, latex, or polyurethaneelastomer.

As shown in FIG. 1, intragastric anchor 10 is a collapsible, fixationdisc which can be inserted through the stomach wall via tube 12 with asecond channel 16 that extends through each expandable device 4. Thedisc, once opened in the stomach, anchors expandable device 4 againstthe stomach. Once intragastric anchor 10 is positioned within thestomach and unfolds, an attached suture may be pulled to form a snug fitbetween the exterior surface of the stomach body and expandable devices4. The size and shape of intragastric anchor 10 is chosen to complementthe inner surface of the stomach, and to provide a sufficient surfacearea (when unfolded) to prevent intragastric anchor 10 from dislodgingfrom the stomach when tension is applied. Intragastric anchor 10 shouldbe made of a biocompatible material capable of shape memory, e.g.,nitinol coated with polytetrafluoroethylene.

An access device 6 comprises ports (not shown) to filling tubes 12. Thesize and shape of access device 6 is adapted to allow for a tight sealwith filling tubes 12 and a fluid carrier (e.g., a hypodermic syringe).The number of ports is determined by the number of tubes (12 and 14)that need to be accessed from the outside.

A preferred method of implanting the gastric reduction assembly is to gothough the skin with a minimally invasive puncture. For example, anasogastric tube (Bard, Covington, Ga.) is inserted into the stomach.The stomach is then inflated to better visualize it under fluoroscopy sothat the proper location for an access site through the skin can bedetermined. The access site should be below the rib cage, near thegastric chamber. Once the access site is determined, a micropunctureneedle (e.g., 22 g; Cook, Inc., Bloomington, Ind.) is inserted into theperitoneal cavity immediately in front of the anterior gastric wall. Amicrowire (e.g., 0.018 in; Cook, Inc., Bloomington, Ind.) is passedthrough the needle under fluoroscopic guidance and into the peritonealcavity. Once the microwire reaches the peritoneal cavity, themicropuncture needle is removed over the wire.

An access sheath (e.g., 6 French introducer; Cook, Inc., Bloomington,Ind.), a hollow tube that fits through the skin to form a temporarypathway to the peritoneal cavity, is then inserted over the microwire.The microwire is then removed, leaving the access sheath in place. Aguidewire (e.g., 0.035 in stiff regular or hydrophilic; BostonScientific, Natick, Massachusetts.) is then inserted through the accesssheath to provide additional support. The opening in the abdominal wallis progressively dilated with dilators (Cook, Inc. Bloomington, Ind.)from 6-14 French. When the opening is sufficiently large, a largeraccess sheath (e.g., 14 Fr peel-away sheath; Cook, Inc. Bloomington,Indiana) is placed over the 0.035 in stiff guidewire, and the dilatorand guidewire are removed. Air is then evacuated from the stomachthrough the nasogastric tube to provide space for the gastriccompression assembly 2.

Introducer tubes (e.g., catheters) containing expandable devices 4(e.g., balloons) attached to filling tubes 12 are inserted through theaccess sheath to a predetermined position near the stomach. Expandabledevices 4 are released from the introducer tubes. The expandable devices4 are then partially inflated sequentially near the stomach using asyringe to introduce fluid (e.g., CO2, isotonic saline solution, orisotonic dextrose solution) to the expandable devices 4 through thefilling tubes 12. Introducer tubes are slowly withdrawn, and eachfilling tube 12 is pulled until each partially inflated expandabledevice 4 contacts the abdominal wall. The access sheath is then removed,and a subcutaneous anchor 8 (e.g., a balloon or ring lock) is placedwithin the fatty layer between the skin and abdominal wall or thesubperitoneal region (i.e., below the abdominal wall) to anchorexpandable devices 4. Expandable devices 4 are then inflated to a volumesufficient to compress the stomach, and filling tubes 12 cut to anappropriate length. The inlets to filling tubes 12 are then attached tothe ports of access device 6, and access device 6 is placed within thefatty layer between the skin and abdominal wall. The skin is then closedwith sutures.

In an alternative embodiment, each expandable device 4 is individuallyintroduced to a preselected stomach compression site near the stomachand then anchored to the stomach, as described below. In thisembodiment, filling tube 12 to each expandable device 4 has at least twochannels. Filing tube 12 is positioned to pass through expandable device4 and abut the side of expandable device 4 that is near the stomach. Onechannel of filling tube 12 has an opening that allows fluid to flow intoexpandable device 4 to inflate the device. The second channel of fillingtube 12 passes intact through expandable device 4 to the wall near thestomach. This channel allows an intragastric anchor 10 to be placedinside the stomach to help anchor expandable device 4 as describedbelow. Initially, a needle (e.g., an 18-gauge needle; Cook, Inc.Bloomington, Ind.) is passed through the access sheath to puncture thestomach wall. A contrast medium (e.g. gastrograffin) is then injectedinto the stomach to determine the needle's location. Once the locationis determined, a suture 22 is attached to intragastric anchor 10, andthe collapsed anchor is advanced through the needle into the stomach ina collapsed form using a stiff guidewire (e.g., 0.035 cm guidewire;Boston Scientific Corp, Natick, Mass.). Upon exiting the needle outletwithin the stomach, intragastric anchor 10 resumes its disc-shapedconfiguration. Intragastric anchor 10 can be covered with abiocompatible material (e.g., GORTEX®, DACRON®, polyethylene orsilicone) to help seal the gastric puncture site. The 18-gauge needle isthen removed, while the stiff guidewire and suture remain attached tothe intragastric anchor 10. Preferably, suture 22 is attached to theguidewire to allow for withdrawal. This process is repeated for each ofthe remaining expandable devices 4. The stiff guidewire is then passedthrough the second channel of filling tube 12 for each expandable device4. Expandable devices 4 are then positioned at preselected stomachcompression sites as described above. After verifying the compressiveeffects of each expandable device 4 on the gastric volume of thestomach, the stiff guidewires are disconnected from sutures 22 andremoved. Each suture 22 is then pulled back through the second channelof filling tube 12 to anchor the device to the stomach wall. The accesssheath is then removed, and filling tubes 12 are cut to an appropriatelength. The ends of each suture are pulled through the second channeland attached to access device 6 to anchor expandable devices 4.Expandable devices 4 can then be inflated or deflated through accessdevice 6, as necessary. Access device 6 is then placed within the fattylayer between the skin and the abdominal wall, and the skin is closedwith sutures.

Clinical trials will initially involve testing two groups (a test and acontrol) of pigs weighing more than 50 kg. The gastric reductionassembly will be implanted into the test group. Once the gastricreduction assembly has been implanted, an upper gastrointestinal study(“UGI”) will be conducted with barium to check the gastric volume andpassage of material through the stomach into the small intestine. Thevolume of the expandable devices will be adjusted in the test groupbased on the findings of the UGI. UGIs will be conducted at variousintervals to check on the location and volume of the expandable devices.The two groups will be weighed weekly. After six months, the animalswill be euthanized and the position of the gastric reduction assemblyevaluated during necropsy. The data will be analyzed for differences inweight loss between the two groups.

The complete disclosures of all references cited in this specificationare hereby incorporated by reference. In the event of an otherwiseirreconcilable conflict, however, the present specification shallcontrol.

1-105. (canceled)
 106. A method of fastening a device to one wall of agastrointestinal organ comprising: passing said device through apatient's abdominal skin, wherein the device is in an undeployedconfiguration; passing an anchor through a patient's abdominal skinwherein said anchor is in an undeployed configuration; deploying saiddevice; connecting said device and said anchor by a connector such thatsaid anchor and device are fastened to a wall of said gastrointestinalorgan by said connector, wherein said connector prevents said device andsaid anchor from moving apart; and deploying said anchor to its deployedconfiguration; wherein said device induces satiety in said patient. 107.The method of claim 106, wherein said connector is a suture.
 108. Themethod of claim 106, wherein the gastrointestinal organ is the stomach,and said device is located outside the stomach.
 109. The method of claim108, wherein said anchor is located at least partially inside thestomach, said device comprises an inflatable balloon and said connectoris a suture.
 110. The method of claim 106, wherein said device comprisesan inflatable balloon.
 111. The method of claim 106, wherein said anchoris covered with a mesh and said connector is a suture.
 112. The methodof claim 106, wherein the gastrointestinal organ is the stomach, saiddevice comprises an inflatable balloon, and said anchor is locatedoutside of the stomach.
 113. The method of claim 112, wherein saiddevice is located outside of the stomach.
 114. The method of claim 106,wherein the gastrointestinal organ is the stomach, said device islocated outside of the stomach, said connector is a suture and saidanchor is covered with a mesh.
 115. A method of treating an obesepatient comprising: penetrating through the abdominal wall of a patientwith a balloon adapted to track over a connector, wherein the balloon isexpandable from a first undeployed configuration to a second deployedconfiguration, and wherein the balloon is fixed to a least two pointsinside the abdomen and wherein the balloon is further contoured tomaintain contact with the gastrointestinal organ.
 116. A method ofplacing a device to restrict flow of food in to the stomach of a patientcomprising: penetrating the abdominal wall of a patient; contacting thestomach of the patient with a connector; pushing an extragastric balloonthrough the abdominal wall while the extragastric balloon is in contactwith the connector and while the extragastric balloon is undeployed andthence contacting the stomach of the patient with the balloon; andfixing the extragastric balloon to an outer portion of the stomach. 117.The method of claim 116, further comprising cutting the connector sothat the residual of the connector remains in the abdominal cavity. 118.The method of claim 116, further comprising cutting the connector sothat the residual of the connector traverses at least a part of theabdominal wall.
 119. The method of claim 118, further comprisingattaching an access port to the connector operable to inflate or deflatethe extragastric balloon.
 120. The method of claim 116, furthercomprising visualizing the connector under fluoroscopy.
 121. The methodof claim 116 wherein said method is performed laparoscopically.